The monoclonal antibody (mAb) is the first respiratory syncytial virus (RSV) prevention approved to protect all infants in the U.S. through their first RSV season, and it will be available ahead of the 2023-2024 RSV season.
The news: The Center for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) voted unanimously to add Beyfortus to the list of routine immunization for infants, and CDC Director Dr. Mandy Cohen adopted the recommendation.
Federal support for access: ACIP also unanimously supported covering Beyfortus under the Vaccines for Children Program for kids without insurance or who cannot otherwise afford to receive it.
Why it matters: “RSV is the most common cause of bronchiolitis in children younger than one year old and causes approximately 58,000 hospitalizations among children under five annually,” says the National Institutes of Health. An unusual surge of RSV last year underscored the need for protection.
Ready for rollout: The makers of Beyfortus, BIO members AstraZeneca and Sanofi, say the drug will be available in the United States ahead of this fall’s RSV season.
What they’re saying: “It really does give promise to maybe one day making RSV in infants a disease for the medical history books," said Dr. Jose Romero, Director of the CDC’s National Center for Immunization and Respiratory Diseases (NCIRD), at the conclusion of the ACIP meeting.
BIO’s take: “This news represents a milestone for innovation in prevention and will be an important addition to our growing set of preventive solutions for RSV,” says Phyllis Arthur, BIO’s SVP of Infectious Disease and Emerging Science Policy.